This invention relates to the application of specific antimicrobial agents to diapers and wet wipes for the protection of infants from strains of the bacterium Staphylococcus aureus, which is known to be a causative agent of toxic shock syndrome (TSS). Toxic shock syndrome is a severe, toxin-induced disease caused by infection with toxic shock syndrome toxin-1 (TSST-1) (Iandolo, Ann. Rev. of Micro. 43:275–402, 1989) which is produced by Staphylococcus aureus, and is characterized by sudden onset of symptoms including high fever, chills, rash, vomiting and/or diarrhea, and a rapid drop in blood pressure, which often leads to shock. While most commonly seen in menstruating women, in whom the primary site of infection is vaginal, the syndrome has also been reported in infants, children, men, and nonmenstruating women at a lower frequency rate. In such cases, skin wounds or Staphylococcus aureus infection in other sites in the body are believed to be the cause of TSS. The rate of incidence of the syndrome in the United States is about two cases per 10,000 persons annually.
While the disease may be treated with antibiotics and by administration of intravenous fluids to maintain blood pressure, many persons suffering from toxic shock syndrome may not receive appropriate medical intervention before serious complications result, due to the sudden onset of the syndrome. This is particularly true in the case of infants and children. Typically, such complications may include kidney failure, heart failure, liver failure, and profound shock.
Because TSS has such a rapid onset, and may be life-threatening, there is a very strong emphasis on disease prevention, with most of the concentration being upon menstruating women, who are at increased risk of developing TSS through the use of highly absorbent tampons or barrier contraceptives. Various approaches to preventing the development of toxic shock syndrome from tampon use have been advanced, including incorporating bactericidal or bacteriostatic agents such as antibiotics or phenol into tampons to inhibit grown of Staphylococcus aureus; incorporating agents which prevent the production of TSST-1, or inactivate TSST-1; and mechanical improvements to tampons which prevent harmful bacteria from being introduced into or colonizing within the vagina.
A number of U.S. patents have issued relative to this matter, including U.S. Pat. No. 4,405,323, the content of which is incorporated herein by reference, as if fully set forth herein, which discloses a tampon having an antibacterial agent such as povione-iodine, mercury, zinc, penicillin, erythromycin, or nitrofurazone, incorporated therein. U.S. Pat. No. 4,431,427, the content of which is incorporated herein by reference, as if fully set forth herein, discloses a tampon incorporating a water-soluble acid, such as citric, glycolic, malic, tartaric, or lactic acid, in an amount sufficient to maintain a pH of less than 4.5 in the fluids absorbed in a tampon, so as to inhibit growth of pathogenic bacteria.
It is also known that some hop acids produced in the brewing of beer can inhibit the growth of microorganisms. U.S. Pat. No. 5,082,975, the content of which is incorporated herein by reference, as if fully set forth herein, discloses that the hop acid hexahydrolupulone can inhibit the growth of Lactobacillus without inhibiting yeast. Similarly, U.S. Pat. No. 5,455,038, the content of which is incorporated herein by reference, as if fully set forth herein, teaches that Listeria in a medium or in food may be inhibited by contact with an effective amount of hexahydrocolupulone, tetrahydroisohumulone, or a salt of hexahydrocolupulone or tetrahydroisohumulone. Hop acids are relatively inexpensive, making their use to inhibit growth of organisms attractive. Also, resistance of Staphylococcus aureus has not been described as has the resistance to various antibiotics. The term “tetrahydroisohumulone” as used herein includes a mixture of tetrahydroisohumulone, tetrahydroisoadhumulone and tetrahydroisocohumulone. The mixture is commercially available, or can be prepared for example by use of the method of the Cowles et al. U.S. Pat. No. 4,644,084, the content of which is incorporated herein by reference, as if fully set forth herein. The hexahydrocolupulone is a known compound which can be made by the chemical hydrogenation of colupulone with platinum (IV) oxide as the catalyst as described by W. Reidl, J. Nickl, Ber; 89 (1956) p. 1863, or J. F. Carson, J. Am. Chem. Soc., 73 (1951) p. 1850.
Further, Nutter et al. disclosed in U.S. Pat. No. 5,827,895, the content of which is incorporated herein by reference, as if fully set forth herein, that hexahydrolupulones and hexahydrocolupulones may be used to inhibit the growth of Staphylococcus aureus. Nutter et al. also reported that the antimicrobial activity of hexahydrolupulones is highly specific for gram positive bacteria, such as Staphylococcus aureus. 
In addition, Todd et al, in U.S. Pat. No. 5,166,449, the content of which is incorporated herein by reference, as if fully set forth herein, note the antibacterial activity of beta acids (lupulone), as a constituent of hops, and methods for their conversion to tetrahydroiso-alpha and hexahydro-beta acids. The patent also teaches the use of such compounds for inhibition of the bacterium Lactobacillus. 
However, no methods have to date been found to effectively eliminate or inhibit growth of Staphylococcus aureus, or toxins produced thereby, in skin wounds or other sites of the body, particularly in infants. Since infants are sensitive to TSS, and infants of diaper wearing age particularly so, a means to prevent TSS associated with infection from skin contact has been sought.